Table 2.
Adverse Events / CTCAE Grade | Level 1 | Level 2a | Level 2b | Level 3 | Total | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
n = 3 | n = 3 | n = 3 | n = 6 | n = 15 | ||||||||||||||||
1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 | |
Neutropenia | 0 | 0 | 2 | 1 | 0 | 1 | 1 | 1 | 0 | 0 | 2 | 1 | 0 | 0 | 4 | 2 | 0 | 1 | 9 | 5 |
Leukopenia | 0 | 0 | 3 | 0 | 0 | 1 | 2 | 0 | 0 | 2 | 1 | 0 | 1 | 1 | 3 | 1 | 1 | 4 | 9 | 1 |
Alopecia | 3 | 0 | NA | NA | 1 | 2 | NA | NA | 0 | 2 | NA | NA | 2 | 4 | NA | NA | 6 | 8 | NA | NA |
Peripheral sensory neuropathy | 1 | 0 | 1 | 0 | 0 | 2 | 1 | 0 | 0 | 2 | 0 | 0 | 3 | 3 | 0 | 0 | 4 | 7 | 2 | 0 |
Anemia | 1 | 1 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 2 | 0 | 0 | 2 | 4 | 0 | 0 | 3 | 8 | 1 | 0 |
Diarrhea | 1 | 1 | 0 | 0 | 2 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 3 | 2 | 0 | 0 | 7 | 4 | 1 | 0 |
Decreased appetite | 2 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 1 | 1 | 0 | 4 | 1 | 0 | 0 | 8 | 3 | 1 | 0 |
Nausea | 2 | 0 | 0 | NA | 2 | 0 | 0 | NA | 2 | 1 | 0 | 0 | 2 | 1 | 0 | 0 | 8 | 2 | 0 | 0 |
Stomatitis | 2 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 4 | 0 | 0 | 0 | 8 | 2 | 0 | 0 |
Fatigue | 1 | 0 | 0 | NA | 0 | 2 | 0 | NA | 1 | 1 | 1 | NA | 1 | 1 | 2 | NA | 3 | 4 | 3 | NA |
Dysgeusia | 1 | 0 | NA | NA | 3 | 0 | NA | NA | 0 | 1 | NA | NA | 4 | 0 | NA | NA | 8 | 1 | NA | NA |
Skin hyperpigmentation | 1 | 0 | NA | NA | 1 | 0 | NA | NA | 2 | 0 | NA | NA | 4 | 1 | NA | NA | 8 | 1 | NA | NA |
Dry skin | 0 | 1 | 0 | NA | 0 | 1 | 0 | NA | 1 | 1 | 0 | NA | 4 | 0 | 0 | NA | 5 | 3 | 0 | NA |
ALT level increased | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 1 | 0 | 5 | 0 | 1 | 0 |
AST level increased | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 1 | 0 | 5 | 0 | 1 | 0 |
Myalgia | 1 | 1 | 0 | NA | 1 | 0 | 0 | NA | 2 | 0 | 0 | NA | 1 | 0 | 0 | NA | 5 | 1 | 0 | NA |
Abdominal pain | 0 | 0 | 0 | NA | 1 | 1 | 0 | NA | 0 | 2 | 0 | NA | 2 | 0 | 0 | NA | 3 | 3 | 0 | NA |
Peripheral edema | 0 | 0 | 0 | NA | 1 | 1 | 0 | NA | 0 | 0 | 0 | NA | 2 | 2 | 0 | NA | 3 | 3 | 0 | NA |
Lymphopenia | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 2 | 1 | 0 | 0 | 3 | 3 | 0 |
Constipation | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 5 | 0 | 0 | 0 |
Thrombocytopenia | 2 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 5 | 0 | 0 | 0 |
Watering of eyes increased | 0 | 0 | 0 | NA | 0 | 0 | 0 | NA | 1 | 0 | 0 | NA | 4 | 0 | 0 | NA | 5 | 0 | 0 | NA |
ALT, Alanine aminotransferase; AST, Aspartate aminotransferase; CTCAE, Common Terminology Criteria for Adverse Events; NA, not applicable